Home NDC 0548-9601 NEOSTIGMINE METHYLSULFATE
Product NDC 0548-9601
11-digit product format 005489601
Labeler code 0548
Product ID 0548-9601_32069cca-ad21-4afc-9c23-5ab376b0237a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name neostigmine methylsulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Amphastar Pharmaceuticals, Inc.
Application ANDA209933
Marketing category ANDA
Marketing start 2017-09-25
Substance NEOSTIGMINE METHYLSULFATE
Active strength .5 mg/mL
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209933-001 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 A209933-002 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209933-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209933-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-09-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base NEOSTIGMINE METHYLSULFATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEOSTIGMINE METHYLSULFATE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98IMH7M386 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311935 Internal RxNorm lookup 311936 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0548-9601-00 NEOSTIGMINE METHYLSULFATE 10 in 1 PACKAGE INJECTION 10 6 0548-9601-00 NEOSTIGMINE METHYLSULFATE 1 in 1 CARTON INJECTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0548-9601 NEOSTIGMINE METHYLSULFATE INJECTION [AMPHASTAR PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20220827_e47a4a4c-0e7c-40b6-9950-5b3adadcac22.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0548-9601-00 00548960100 10 CARTON in 1 PACKAGE (0548-9601-00) / 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE 10 carton 2017-09-25 0000-00-00 No No Current